Over One-Third of HCV Patients Denied DAA Tx by Payers

https://www.medpagetoday.com/infectiousdisease/hepatitis/73368

Highest among commercial insurers, increased over study period

More than a third of chronic hepatitis C (HCV) patients were denied access to direct-acting antiviral (DAA) treatment by their insurance provider, researchers found.

Among patients prescribed DAAs, 35.5% (95% CI 34.5%-36.5%) had their prescriptions denied by their insurer, reported Charitha Gowda, MD, of Ohio State University College of Medicine in Columbus, and colleagues.

Not only that, but the proportion of hepatitis C patients whose DAA prescriptions were denied by their insurance company increased over a period of 16 months, the authors wrote in the study online in Open Forum Infectious Diseases.

The authors noted that despite the benefits of HCV therapy, research in Clinical Infectious Diseases indicates that the high cost of DAAs has led public and private insurers to restrict access to these medications, and that insurers required “varying criteria for reimbursement” such as “evidence of advanced liver fibrosis, consultation with a specialist, and/or abstinence from alcohol or illicit drug use,” according to studies in Hepatology and Journal of Hepatology.

While advocacy efforts, threatened lawsuits, and greater price competition led some insurers to ease these restrictions, the Gowda and co-authors said their aim was to examine how access to DAAs has changed.

The team examined data from patients filling a prescription for DAAs from Diplomat Pharmacy Inc., which was described by the authors as providing “specialty pharmaceuticals” to patients across the U.S.

From January 2016 to April 2017, the system received prescriptions from 9,025 patients for DAAs — 4,702 covered by Medicaid, 2,502 covered by commercial insurance, and 1,812 covered by Medicare. Patients were a median 57 years old, and 38.4% were women. Over half were prescribed sofosbuvir/ledipasvir with or without ribavirin.

The authors noted that denial of treatment was more common among patients with commercial insurance (52.4%) compared with those with Medicaid (34.5%) or Medicare (14.7%, P<0.001 for both). The incidence of absolute denial increased across the study period, from 27.7% in the first quarter to 43.8% in the last quarter (test for trend, P<0.001).

Out of 45 examined states where a DAA prescription was submitted, eight states contributed 90% of prescriptions. Pennsylvania had the highest proportion (31.5%), followed by California (23.6%) and Michigan (14.3%). However, when the researchers examined the overall incidence of absolute DAA denial in these eight states, Maryland had the highest incidence (51.5%), followed by Delaware (49.1%), New Jersey (47.2%), and Pennsylvania (45.7%).

The authors emphasized the important clinical implications of the findings — namely that “persons denied access to HCV therapy remain at risk for the development of hepatic fibrosis, cirrhosis, liver decompensation, and hepatocellular carcinoma,” as well as ongoing HCV-associated inflammation that could lead to extrahepatic complications.

The team also pointed out the potential public health impact — i.e., that lack of access to DAAs could impede the goal of HCV elimination. The researchers cited a recent report from the National Academies of Sciences, Engineering, and Medicine that recommended that “public and private insurers should remove restrictions to DAAs that are not medically indicated and offer treatment to all chronic HCV-infected patients,” which is also consistent with guidelines from the American Association for the Study of Liver Diseases/Infectious Diseases Society of America.

Healthcare/Insurance… just your basic FOR PROFIT BUSINESS

Half of hepatitis C patients with private insurance denied life-saving drugs

https://medicalxpress.com/news/2018-06-hepatitis-patients-private-denied-life-saving.html

The number of insurance denials for life-saving hepatitis C drugs among patients with both private and public insurers remains high across the United States, researchers from the Perelman School of Medicine at the University of Pennsylvania reported in a new study published in the journal Open Forum Infectious Diseases. Private insurers had the highest denial rates, with 52.4 percent of patients denied coverage, while Medicaid denied 34.5 percent of patients and Medicare denied 14.7 percent.

The data was revealed through a prospective analysis of over 9,000 prescriptions submitted to a national specialty pharmacy between January 2016 and April 2017.

Direct-acting antiviral drugs (DAAs) – once-a-day pills that first became available in the United States in 2014—are highly effective, with a 95 percent cure rate and few side effects for with chronic C, but expensive. Because they can cost between $40,000 and $100,000, both private and public insurers have restricted access to the medications, approving the drugs only for patients with evidence of advanced liver fibrosis and/or abstinence from alcohol or illicit use, for example.

More recently, some of those restrictions had been relaxed because of vocal stakeholders and leaders, class action lawsuits, and greater drug price competition that experts believed would help increase the overall approvals by insurers. However, analysis of the data suggests otherwise.

“Despite the availability of these newer drugs and changes in restrictions in some areas, insurers continue to deny coverage at alarmingly high rates, particularly in the private sector,” said study senior author Vincent Lo Re III, MD, MSCE, an associate professor of Infectious Disease and Epidemiology. “It warrants continued attention from a public health standpoint to have more transparency about the criteria for reimbursement of these drugs and fewer restrictions, particularly in private insurance and certainly to continue the push in public insurance, if we want to improve hepatitis C drug access across all states.”

The reason for the higher than expected denial rate is unclear, the authors said, but may be due to the varying restrictions on reimbursements that exist among the states. It’s likely there were more attempts to treat patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist, they wrote.

The team analyzed prescriptions from 9,025 patients between January 2016 and April 2017 submitted to Diplomat Pharmacy Inc. throughout 45 states. Among those patients, 4,702 were covered by Medicaid; 1,821 by Medicare; and 2,502 by commercial insurance. In all, 3,200 (35.5 percent) were denied treatment.

The denial rates appear to be increasing, as well. The overall incidence of denials across all insurance types increased during the study period from 27.7 percent in the first quarter to 43.8 percent in the final quarter. In addition, a Penn study from 2015 found that just five percent who had Medicare received a denial, while 10 percent who had private insurance did.

That same study also found that 46 percent of Medicaid patients were denied coverage, compared to the current study’s 35.7 percent. A statement from the Centers for Disease Control and Prevention in 2015 indicating that restrictions violated federal law prompted class action suits and legal action against Medicaid, which likely contributed to the public insurer easing its criteria across some states and improved approval rates, the authors said. Still, Medicaid denials increased over the study period.

“From a clinical standpoint, patients with chronic hepatitis C who are denied therapy can have continued progression of their liver fibrosis and remain at risk for the development of liver complications, like cirrhosis, hepatic decompensation, and liver cancer,” Lo Re said. “In addition, chronic hepatitis C promotes not only liver inflammation, but systematic inflammation, which can lead to adverse consequences on organ systems outside of the , such as bone, cardiovascular, and kidney disease. Further, untreated patients can continue to transmit infection to others.”

A recent report from the National Academies of Science, Engineering, and Medicine determined that at least 260,000 chronic hepatitis-infected patients must be treated yearly to achieve elimination of the virus in the United States by 2030. To reach that goal, they recommended that public and remove restrictions to the hepatitis C drugs that are not medically indicated and offer treatment to all C-infected patients. Those recommendations are also consistent with guidelines from the American Association for the Study of Liver Diseases and Infectious Diseases Society of America.

“Eliminating hepatitis C in the U.S. is a feasible goal,” Lo Re said, “but that’s going to be hard to achieve if payers are not reimbursing for the treatment.”

Explore further: Insurance denials for new hepatitis C drugs remain high nationwide, study suggests

I will believe this when the CDC and DEA make similar statements and take action.

FDA Commissioner Says FDA Will Listen to Chronic Pain Patients About Opioids

www.themighty.com/2018/05/fda-chronic-pain-patients-opioids/

In a blog post published on Monday, Scott Gottlieb, the Food and Drug Administration commissioner, said the FDA is listening to opioid-related concerns from patients with chronic pain.

“We’ve heard the concerns expressed by these individuals about having continued access to necessary pain medication, the fear of being stigmatized as an addict, challenges in finding health care professionals willing to work with or even prescribe opioids, and sadly, for some patients, increased thoughts of or actual suicide because crushing pain was resulting in a loss of quality of life,” Gottlieb wrote.

Over a year ago, the FDA created the Opioid Policy Steering Committee with the goal of reducing exposure to opioids, preventing more addictions and developing and cultivating the use of medications to treat opioid addiction. This committee received public input from patients who use opioids to manage their chronic pain.

Now, the FDA is asking for input from chronic pain patients again to learn more about the “impacts of chronic pain, [patient] views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments.”

Gottlieb said the FDA wants to “strike the right balance” between making policies that give patients who need opioids the proper accessibility and preventing opioid exposures that lead to new addictions.

Most patients with chronic pain do not develop an addiction. While studies vary on percentages, one study stated that less than 1 percent of those who take opioids long-term develop an addiction. Another study said 8 to 12 percent of people with chronic pain develop an addiction. This study also said that misuse (but not addiction) of opioids among chronic pain patients can be between 21 to 29 percent.

The FDA is considering coming up with a strategy in the next few months to encourage medical professional societies to create evidence-based guidelines on how to prescribe medications for acute medical needs and assess prescribing behavior as well as adding new prescribing information to opioid labels.

Gottlieb wrote:

We believe such guidelines could encourage the use of an appropriate dose and duration of an opioid for some common procedures and promote more rational prescribing, including that patients are not being under prescribed and patients in pain who need opioid analgesics are not caught in the cross hairs. In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren’t over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.

The Centers for Disease Control and Prevention published guidelines for prescribing opioids for chronic pain in 2016. The guidelines were not well received by patients, who said the guidelines led to less doctors prescribing opioids for their pain.

Gottlieb also said the FDA will be developing guidance documents for the most efficient path for developing drugs that can be used to treat various types of pain. This is an effort to promote more drug innovation for pain.

Patients with chronic pain can attend the FDA’s “Patient-Focused Drug Development for Chronic Pain” meeting on July 9 from 10 a.m. to 4 p.m. Patients can attend in person in Maryland or through a webinar by registering online.

Healthcare is just a FOR PROFIT BUSINESS… MORE PROFITS… results in poorer outcomes for pts ?

https://www.medpagetoday.com/publichealthpolicy/opioids/73289

After Medicaid Privatization, Steep Cuts in Care

The Dallas Morning News launched a series they’re calling “Pain and Profit,” which looks at how companies paid by the state to handle Medicaid issues fall short. The first installment explored the case of a baby named D’ashon Morris who needs assistance to breathe. In the months before his first birthday, D’ashon began pulling out his trach tube. Despite evidence that it was a constant problem, the company supervising his care ruled that he did not require around-the-clock care. Physicians called it a matter of life and death.

It didn’t matter. He didn’t get the care. His tube dislodged one night; he’s now brain dead. The second piece, highlighting care to poor adults, published Monday.

When Opioids Are Discouraged, Pain Gets Short Shrift

Physicians’ growing discomfort prescribing opioids — and the federal government’s efforts to curb prescription rates — has left those in chronic pain in the lurch, the Washington Post reports. Some are flying across the country to find a prescription, while others are turning to unregulated substances such as kratom.

“I am seeing many people who are being harmed by these sometimes draconian actions amid this headstrong rush into finding a simple solution to this incredibly complicated problem,” said Sean Mackey, chief of Stanford University’s Division of Pain Medicine. “I do worry about the unintended consequences.”

Do we need to educate the professionals?

Do we need to educate the professionals?

www.nationalpainreport.com/do-we-need-to-educate-the-professionals-8836437.html

Some professionals claim to be “experts”; however, few are experts in the entire scope of their chosen field of study. Most likely they will end up being “specialists” in certain subsets of their profession. Either because they have become interested in one or more subsets, or that is where there is a need to provide services.

Has anyone noticed that there are seemingly endless array of personal injury attorneys appearing on TV, offering to sue someone because someone has gotten injured or died?

Most seem to focus on trucking/vehicles accidents, nursing home neglect, and other areas where there is some entity with a “deep pocket” to sue.

I have heard or read from countless chronic pain patients, about them contacting an attorney to sue over patient abuse/neglect/discrimination – and all have been turned down.

They are being turned down because in our legal system, the “value of life” of a person who is handicapped/disabled, elderly, unemployable, retired, is about the same as the value of the family pet… nearly ZERO. Likewise, if a law firm did take such a case, most states have a rather low cap on settlements… To a point where there is no financial upside for the law firm for winning the case.

But the “the times they are a changing”… An increasing number of various healthcare entities are seemingly taking it upon themselves to practice medicine. Some of those entities are insurance companies, PBM’s, large hospital corporations, chain pharmacies and other such entities.

They are creating edicts that their employed prescribers, pharmacists and others are to limit/restrict controlled medications – regardless of what the patient’s personal prescriber deems necessary.

Beside attempting practicing medicine without a license, they are discriminating against a protected class of people under the Americans with Disability Act, Civil Rights Act and numerous other legal issues.

What do these healthcare businesses have in common with the entities that these personal injury attorney normally sue?  DEEP POCKETS!!!

Now is the time for chronic pain patients to start contacting law firms and point out to them – EDUCATE THEM… all the patient abuse, neglect and discrimination that is going on at the hands of these corporate entities that are called “healthcare companies” – and individually these companies are harming hundreds, thousands or tens of thousands of chronic pain patients.

With 20 to 30 million intractable chronic pain patients in our country, the total number of patients being affected is really not known. All we know is that whatever the number is today, it is GROWING.

OR… you can keeping contacting President Trump, members of Congress, signing petitions and creating hundreds of Facebook pages… and how has that been working for you?

 

DEA says it Won’t Prohibit Cannabis Stems, Seeds for Product Use, Sale

www.mgretailer.com/dea-says-it-wont-prohibit-cannabis-stems-seeds-for-product-use-sale/

WASHINGTON D.C. –The Drug Enforcement Agency (DEA) on May 22 issued an internal directive that apparently acknowledges some cannabis products are not currently prohibited under the Controlled Substances Act (CSA) and that specific parts of cannabis plants are not prohibited for use under current policy.

According to the directive, the DEA’s enforcement policy is consistent with a 2004 decision handed down by the U.S. Ninth Circuit Court of Appeals, in Hemp Industries Association v. DEA.

The directive stated:

“Products and materials that are made from the cannabis plant and which fall outside the CSA definition of marijuana (such as sterilized seeds, oil or cake made from the seeds, and mature stalks) are not controlled under the CSA. Such products may accordingly be sold and otherwise distributed throughout the United States without restriction under the CSA or its implementing regulations. The mere presence of cannabinoids is not itself dispositive as to whether a substance is within the scope of the CSA; the dispositive question is whether the substance falls within the CSA definition of marijuana.”

The directive also said that the policy directive did not change the DEA’s current policy toward cannabis extracts and resin.

Cannabis law firms reacted to the directive, which in effect, potentially clears the way through the dense legal grey area for CBD or hemp-based products, and could signal a boon to cannabis/hemp growers and product manufacturers.

Canna Law Blog™ refined the definition of parts of cannabis plants that the DEA has said are exempt for use in product manufacturer. They include:

  • Mature stalks
  • Fiber produced from mature stalks
  • Oil or cake made from seeds
  • Seeds incapable of germination

The DEA directive also said that “any other compound, manufacture, salt, derivative, mixture, or preparation” created from named plant parts were also not prohibited, though Canna Law pointed out any extracted resin is still considered “marijuana” by the DEA and would be prohibited under the CSA.

The DEA directive went on to essentially say products produced from non-prohibited ingredients were okay for sale in the United States. Products containing THC, the psychoactive compound in cannabis, and products otherwise designated as marijuana by the DEA were still federally prohibited. Non-THC products, however, would not be prohibited. The directive did not directly address hemp or hemp-based products.

“Such products may accordingly be sold and otherwise distributed throughout the United States without restriction under the CSA or its implementing regulations. The mere presence of cannabinoids is not itself dispositive as to whether a substance is within the scope of the CSA; the dispositive question is whether the substance falls within the CSA definition of marijuana,” the directive said.

Lane & Powell’s The Pipeline Blog said, “… The logical and scientific inconsistency puts the DEA and purveyors of CBD goods in a precarious position: how will they determine which CBD products are subject to the CSA and will people really be prosecuted for trafficking a Schedule I controlled substance where the substance is chemically indistinguishable from one that is not prohibited by the CSA?

“We anticipate that at least one outcome will be buyers insisting on statements or warrantees from sellers, and buyer quality control due diligence, that their CBD products contain only excepted marihuana (sic) oil,” Pipeline blog authors Justin E. Hobson & Lewis M. Horowitz added.

DEA: Foreign fentanyl a greater risk that diverted pills

http://www.dailyitem.com/news/local_news/dea-foreign-fentanyl-a-greater-risk-that-diverted-pills/article_cf376e6e-da2b-577f-b8fa-a6ce4abcf030.html

Fentanyl manufactured in foreign countries and smuggled into the U.S. poses the greater risk compared to the medication illegally diverted by patients and doctors, according to the Drug Enforcement Administration.

The synthetic opioid is up to 50 times more potent than heroin and 100 times that of morphine, the DEA says. It’s increasingly cut into heroin or sold on its own, sometimes to unsuspecting users.

Fentanyl surpassed heroin as the leading opioid detected in fatal drug overdose cases in Pennsylvania two years ago and continues to rise in prevalence.

The Philadelphia Division of the DEA reports 79 percent of overdose deaths in 2017 involved fentanyl, either included in mixed-drug toxicity fatalities or the outright cause. That’s up from 52 percent in 2016.

In the 12 months through October 2017, no state in the country counted more overdose deaths than Pennsylvania’s 5,535, according to the latest provisional data from the Centers for Disease Control and Prevention. An estimated 68,400 fatal overdoses occurred nationally during the same period. Both estimates are on the rise.

“The supply of fentanyl, as determined by law enforcement seizures and intelligence, continues to rise. Fentanyl production is cheaper than heroin production and Transnational Criminal Organizations are increasing their profit by supplying fentanyl over other drugs,” said Laura Hendrick, field intelligence manager for the DEA’s Philadelphia division.

The DEA reports counterfeit opioids mostly manufactured in China and Mexico, and distributed through an illegal supply chain in the U.S., Canada and Mexico as well as the internet’s dark web. Agents in New York, New Jersey and Pennsylvania seized 200,359 grams of fentanyl in 2017, up from 58,102 grams the year before.

Northumberland County set a new record for overdose deaths in 2017: 30. Of those cases, 18 involved fentanyl in some way. Fentanyl was present in seven of 18 drug deaths occurring in Union County since 2016.

Two defendants in Northumberland and Snyder counties, respectively, have criminal cases pending for the alleged sale of fentanyl in unrelated fatal overdose cases.

“It’s much cheaper and they’re using it as a replacement for heroin. People think they’re buying heroin and they’re buying pure fentanyl,” said Todd Owens, a retired police chief and current Northumberland County deputy sheriff who heads the Northumberland-Montour Drug Task Force.

First responders should be more cautious now — surgical masks, thicker exam gloves — as fentanyl and even deadlier derivatives circulate among users, Owens said. There’ve been several confirmed reports of law enforcement or ambulance personnel overdosing themselves on contact with synthetic opioids dusting an overdose patient’s clothing or skin.

Bob Hare, general manager of Sunbury’s Americus Hose Co., said the company’s responders are on high alert for risks involved with all narcotics, not just fentanyl.

“I think our responders are in danger. People are more violent when on these drugs; needles, you got HIV, hepatitis — all things that play into the fact that make it more dangerous today than it has ever been,” Hare said. 

Police continue to make arrests in the Valley for heroin, methamphetamine and the like, particularly in Northumberland County’s coal region. Owens admits the seemingly neverending cycle can wear on law enforcement.

“We arrest one person and two more pop up,” Owens said “It sometimes feels like we’re not winning. It’s frustrating.”

PBM’s: your QOL/life or their bottom line profits… which gets HIGHEST PRIORITIES ?

Mail-order pharmacy system delays meds for some patients

http://www.dispatch.com/news/20180603/mail-order-pharmacy-system-delays-meds-for-some-patients

Imagine the terror of being diagnosed with cancer.

Your doctor writes a prescription that you pray will save your life. You go to the hospital or oncology clinic’s in-house pharmacy. The medicine is right there on the shelf, but you’re told the only way your insurance will cover your medication, which might cost $10,000 or more per month, is if you get it through the mail.

So, you go home empty-handed and wait. If you’re lucky, the medicine will arrive in just a couple of days. But it could be up to a month before delivery of the drugs.

Uncounted numbers of Ohio cancer patients don’t have to imagine this dilemma. They have experienced it because health insurers and the pharmacy benefit managers hired by insurers dictate it.

They require that prescriptions be filled at mail-order pharmacies. These are often owned by the pharmacy benefit managers rather than allowing patients to get the drugs immediately by going down the hall at the James Cancer Hospital at Ohio State University, Cleveland Clinic, Mount Carmel Health System or Nationwide Children’s Hospital.

“Rather than filling a prescription I have on the shelf, I have to tell the patient they have to go home and wait for a phone call from the pharmacy and arrange having this medicine sent to you,” said Christine Pfaff, pharmacist for the Zangmeister Center, a Columbus cancer-treatment facility. “I can’t give it to you today. Your insurance won’t allow it.”

Health-care providers say the goal is to start treatment as soon as possible, because delays can be detrimental to their patients’ health.

“New diagnosis, with medications as good as we have today, speed to therapy is important. Even a few days can make a difference,” said Curt Passafume, vice president of pharmacy services for Ohio Health.

Pharmacist says CVS strong-arms cancer-drug business

http://www.record-courier.com/news/20180603/pharmacist-says-cvs-strong-arms-cancer-drug-business

Josh Cox says that CVS will go pretty far in trying to wrest the lucrative business of filling cancer prescriptions away from oncology clinics.

The company, which operates a retail pharmacy chain and manages prescription-drug payments for millions of Americans, has long sent unsolicited faxes to cancer doctors, using confidential patient information, in an attempt to steer business to its own pharmacies, said Cox, pharmacy director for the Dayton Physicians Network.

CVS says that it does not engage in deceptive practices.

But two weeks ago, Cox said, the company took things to a whole new level when a representative called and told Cox that he would be breaking the law if he didn’t transfer a particular patient’s prescription to CVS’s mail-order pharmacy. Cox said that claim was false.

And he would know. In addition to being pharmacy operations director for a large oncology practice, Cox sits on the Ohio State Board of Pharmacy.

“I was told it was against the law for our pharmacy to fill the prescription, which was very disturbing to me, because not only is that certainly untrue — there are no federal or state of local laws that dictate where a patient can get their prescription — but it took the whole trolling of prescriptions to a whole new level,” Cox said.

CVS has been accused by some pharmacists and lawmakers of using its dominance as Ohio Medicaid’s leading pharmacy-benefit manger to cut reimbursements to competing retail pharmacies and send letters offering to buy them out.

Pharmacy benefit managers are hired by insurers or employers to negotiate prices and rebates with drug makers, decide which medications are covered, and set rates paid to pharmacies.

Ohio pharmacists also say that CVS uses its access to Medicare patients’ information to steer them to its own mail-order and retail pharmacies. Now it and the other dominant PBMs also are being accused by patients and hospital administrators of forcing cancer patients into the PBM’s own mail-order pharmacies, leading to confusion and delays in getting expensive, life-saving drugs, critics say.

On Friday, CVS defended its outreach and its other business practices.

“It is not our policy or practice to mislead or intimidate patients or providers,” spokesman Mike DeAngelis said in an email. “It is common for CVS Caremark to fax prior authorizations and refill requests to providers. A patient’s specialty prescriptions may be moved to CVS Specialty if a client has switched to a preferred or exclusive network when making a change to their plan design. Patients are notified in advance if their plan sponsor chooses to make such a change.”

Cox found the company’s behavior to be unacceptable.

“It was deeply disappointing to me that the process of trying to acquire business, so to speak, had devolved into intimidation tactics among pharmacies,” Cox said.

CBS News Appalling Coverage

This video is not only about the appalling coverage by CBS News but all major news outlets. I could just as easily of named Fox News, the Washington Post or even Andrea McCarren of WUSA Channel 9, Washington DC (another CBS affiliate) who has now blocked me on Tweeter for requesting her assistance in exposing these genocidal policies. Sadly they all REFUSE to contact me even after hundreds of emails, Tweets & even phone calls. America needs to know the truth. President Trump needs to know before he can help. Who among you are willing to spread the horror stories from coast to coast? Remember; just one second! One accident. One diagnosis. In just one second any of you can join us as the 100 million forgotten Americans left to suffer cruel and inhumane torture daily. Robert D. Rose Jr. BSW, MEd. USMC Semper Fidelis